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March 2003

New AIDS Drug May Help Expand Treatable Groups

New findings suggest that an AIDS drug being developed for patients who become resistant to standard treatments may benefit wider groups of people with AIDS. The drug, Fuzeon, is one of a new class of medicines known as fusion inhibitors that researchers are racing to develop to deal with the rapidly mutating HIV virus.

Recent research shows that Fuzeon, thought to be most effective for patients running out of treatment alternatives, works even better for those with lesser degrees of resistance. Drawing from 491 patients divided into four groups of varying levels of response to standard AIDS drugs, researchers from Trimeris Inc. and Hoffmann-La Roche Inc. reported that HIV levels declined in all four groups, which were followed for 24 weeks. The greatest benefit came to patients with lesser degrees of resistance who got their standard cocktail plus Fuzeon. Some saw their virus levels plunge.

Fuzeon's makers, however, continued to sidestep the touchy question of price. Analysts have speculated that Fuzeon -- which takes 106 chemical steps to produce -- may cost as much as $12,000 to $15,000 a year. The companies this month applied to the FDA for permission to market the drug, formerly known as T-20. Roche and Trimeris also plan to bring out a "son of Fuzeon," known as T-1249, "designed to have more potency, a longer half-life in the blood, and more activity against different kinds of HIV, so that it can block viruses that become resistant to Fuzeon," said Trimeris CEO Dan Bolognesi.

Both drugs are given as injections. While Fuzeon's main side effect is skin irritation, three serious reactions arose during T-1249 treatment: fever, an allergy-like hypersensitivity, and neutropenia, or a drop in white blood cells. (Wall Street Journal, 09.30.02, Marilyn Chase)

Study: Hepatitis Shots Show Promise

An experimental new combination of drugs for hepatitis C cures more patients with fewer side effects than the standard treatment for the potentially deadly, liver-destroying infection, researchers say. According to an article in the New England Journal of Medicine ("Peginterferon Alfa-2a Plus Ribavirin for Chronic Hepatitis C," September 26, 2002, Vol. 347, No. 13, P. 975-982), the new treatment could give doctors a more potent weapon against the virus at a time when experts are forecasting a surge in cases of hepatitis liver damage over the next few years.

The experimental treatment involves weekly injections of Pegasys, a long-acting type of interferon called pegylated interferon. Pegasys could be approved for sale in the United States next month. A similar drug, Peg-Intron, went on the market last year. Both are given daily with the antiviral treatment ribavirin. The research was funded by Roche, the Swiss pharmaceutical company that is developing Pegasys and a new brand of ribavirin. Researchers report that six months after the 48-week treatment stopped, Pegasys and ribavirin together eliminated all traces of hepatitis C in 56 percent of the 1,121 patients treated at 81 medical centers worldwide. This compares with 44 percent success with patients receiving the standard treatment -- ribavirin and thrice-weekly shots of the shorter-acting form of interferon. Twenty-nine percent of those in a third group that received the new interferon and a placebo were apparently cured.

"This is one of the first times where we have more than half the people we treat have a good response," said lead researcher Dr. Michael W. Fried, director of liver disease treatment at the University of North Carolina-Chapel Hill. He said Pegasys offers a key advantage over the standard treatment: After 12 weeks of treatment, doctors can tell which patients it probably will cure. The others can stop the six- to-12 month treatment, sparing themselves serious side effects. Pegasys, Peg-Intron and regular interferon have common, serious side effects, including fatigue, flu-like symptoms, nausea, irritability, depression and psychiatric problems. Flu symptoms and depression are slightly less likely with Pegasys. (Associated Press, 09.25.02, Linda A. Johnson)

NYS HIV Names Reporting Falls Short

One of the arguments for the 1998 New York state law requiring health care providers and labs to report the names of people who test HIV-positive was that the data would give a more accurate picture of the AIDS epidemic. But the names reporting effort is not gathering information on whether new infections are occurring among gay and bisexual men, drug users, or other at-risk groups, so city health officials cannot yet say where the epidemic is heading.

"With the change in the law, about 77 percent of our cases come to us via labs and ... many of those reports do not include some of the information like risk [category]," said Dr. Judith Sackoff, deputy director of HIV surveillance and epidemiology at the city's Department of Health.

The department's HIV/AIDS Surveillance Program Semi-Annual Report has no data about whether the 6,084 new HIV infections reported in New York City from June 2000 through December 2001 occurred among gay and bisexual men or injection drug users. "We do have risk information, but because such a large proportion is incomplete, we are not sure what it means," said Dr. Denis Nash, the department's director of surveillance. Assemblymember Nettie Mayersohn, a champion of names reporting, said that gathering risk data was not part of the original legislation.

Part of the problem stems from the volume of information the department now receives. Labs and health providers must report people who are HIV-positive, viral load test results, and CD4 cell counts when the level falls below a certain number. In 2000, when names reporting was implemented, the department received just under 60,000 reports on such tests. It got over 300,000 reports in 2001. Many reports lack complete information, however.

"We are able to describe the demographics and geography [of the epidemic]," said Nash. "The straggling piece on the characterization of the epidemic is the transmission risk." The department will use statistical sampling to "infer the risk distribution," according to the report. It will investigate 5,700 HIV/AIDS cases between June 2000 and December 2001 to determine how those people were infected. A similar investigation from January 2002 will sample 200 to 300 newly reported HIV/AIDS cases each month. (Gay City News (New York City), 09.27.02, Duncan Osborne)

New Insight on Why Some With HIV Can Control Virus

New research suggests that the rare group of people who are infected with HIV for years, receive no treatment and yet show no signs of illness appear to have better function in a certain type of immune system cell than most HIV-positive individuals who cannot control the virus. The findings could lead to new vaccines to prevent and treat HIV infection, said study author Dr. Mark Connors, a senior clinical investigator at the National Institute of Allergy and Infectious Diseases.

Left untreated, most HIV-infected people will begin to develop symptoms of AIDS as their immune systems weaken and they are unable to fend off the replicating virus. But in the small number of patients known as nonprogressors, viral levels in the bloodstream remain low and AIDS does not develop, even though the patient is not treated. Some nonprogressors have now lived as long as two decades with no signs of AIDS.

The latest study, published in the online version of Nature Immunology ("HIV-specific CD8+ T cell proliferation is coupled to perforin expression and is maintained in nonprogressors," 10.07.02, doi:10.1038/ni845), involved a detailed comparison of the immune system function of nonprogressors and progressors. Results showed that the nonprogressors' HIV-fighting CD8 T cells divided rapidly when confronted with HIV-infected CD4 cells, whereas those of progressors did not. In addition, the CD8 cells of the nonprogressors produced more of the HIV-killing protein perforin. Connors described perforin as "a critical molecule that's part of the machinery for killing the infected cell."

The findings suggest that the CD8 cells of nonprogressors respond better than those of progressors when called into action against the virus, Connors said. The results offer new insight into why most people with HIV cannot keep the virus in check naturally and must take powerful antiviral medications to help prevent the disease from progressing, he said. "Understanding the mechanisms by which the immune systems of long-term nonprogressors control HIV is important to our development of effective vaccines," Dr. Anthony Fauci, director of NIAID said in a statement. (Reuters Health, 10.07.02, Jacqueline Stenson)

Hepatitis Worse With HIV/Hepatitis C Coinfection

Liver disease may worsen when there is immunocompetence in hemophiliacs coinfected with HIV and hepatitis C (HCV), investigators have found. Researchers in Athens, Greece, drew this conclusion after studying several factors associated with liver histology in 21 hemophilia patients with HIV and HCV coinfections.

The evaluated patients, whose average age was 35.7 +/- 8.7 years, were in various stages of liver disease, HCV, and HIV. Upon histological evaluation a majority of them demonstrated moderate hepatitis. However, those with higher immune competence showed more severe hepatitis. "Statistical analysis showed a significant association of CD4 count <50 with minimal hepatitis and of CD>200 with mild and moderate hepatitis (p=0.33)," reported J. Delladetsima of the University of Athens Medical School in Greece.

Stage C is a classification for greater symptomatology in HIV infection. Most of the patients with this stage of disease demonstrated only minimal hepatitis, whereas those at stage A, a classification for lesser HIV symptomatology, had mild-to-moderate hepatitis, according to researchers. The full report, "Significance of Immune Status, Genotype and Viral Load in the Severity of Chronic Hepatitis C in HIV Infected Haemophilia Patients," was published in Haemophilia (September 2002;8(5):668-673).

"No relationship was found between hepatitis severity, HIV or HCV RNA levels, patient's age and duration of HIV or HCV infection," researchers noted. Immunocompetence, rather than immunodeficiency, may be a hallmark for more aggressive hepatitis in hemophilia patients coinfected with HIV and HCV, Delladetsima and colleagues suggested. (Hepatitis Weekly, 09.16.02, Sonia Nichols)

Optimism in HIV-Positive Patients May Lead to Risky Moves

New study findings suggest that HIV-positive patients who believe they will live for many years are more likely to miss medication doses and to not practice safe sex than their peers who are less hopeful. Optimism can often help patients cope with a medical condition; but these findings indicate that in the context of HIV, there can be negative consequences to a positive outlook, according to Drs. William C. Holmes and Joseph L. Pace of the University of Pennsylvania-Philadelphia.

The authors surveyed 220 HIV-positive people about their backgrounds, disease history, attitude about their illness and health behaviors. The investigators found that people were more likely to use negative words about being HIV-positive when they were first diagnosed than at the time they completed the surveys. Most of the patients said they thought they would live for many years, and 27 percent said they expected to reach old age. White respondents, those with less education, and patients with relatively low levels of CD4 cells were less likely to hold out hope for the future.

Those patients who said they were relatively optimistic about the future were twice as likely as those with relatively pessimistic outlooks to sometimes forget to take their medications, and they were almost twice as likely to report not practicing safe sex. About 26 percent of optimists and 13 percent of pessimists occasionally forgot to take their medications; 57 percent of optimists and 29 percent of pessimists said they did not always practice safe sex.

In an interview, Holmes said people who are optimistic about the future may become less concerned with the importance of regimen adherence and safe sex. To keep patients optimistic and still safe and healthy, clinicians should educate their patients about the possible negative consequences of good cheer. "Anticipatory discussions with patients can act to help them develop insight about and vigilance against these potential problems," he said.

The full report, "HIV-Seropositive Individuals' Optimistic Beliefs About Prognosis and Relation to Medication and Safe Sex Adherence" was published in the September issue of the Journal of General Internal Medicine (2002;17:677-683). (Reuters Health, 10.03.02, Alison McCook)

HIV Dementia Risk Causes New Concerns

As many as 20 percent of people with HIV may be experiencing problems with the brain's executive secretary: remembering, carrying out complex tasks, organizing paperwork, keeping track of the endless minutiae of a day. And the tasks they need to do to stay alive -- filling prescriptions and swallowing pills on a strict schedule -- are potentially threatened. Doctors are worried that HIV patients, surviving longer thanks to effective treatments, will experience dementia at ages far younger than is customary.

Tests can often pinpoint difficulties that might not yet be obvious: subtle problems with memory, word retrieval, attention and the ability to follow complex directions. As the situation worsens, problems become obvious in everyday chores, missed appointments, lost work and forgotten names.

HIV infects monocytes, common blood cells that can move through the brain's protective membrane, triggering inflammation that changes brain cell physiology. HIV itself can also pass into the brain. Treatment can partially suppress HIV in the brain, said Dr. Gary Blick, who has tested dozens of medicines used in highly active antiretroviral therapy (HAART). But regimens can also come with side effects, including cognitive problems. "It's hard to tease out what's going on," said Dr. Marshall Forstein, medical director of mental health and addiction services at Fenway Community Health. Doctors often overlook memory and thinking problems, or blame them on the stress of the illness. They could also be a signal for depression.

Cognitive decline also has an effect on the drug-taking regimen. Dr. Justin C. McArthur of Johns Hopkins University School of Medicine studied patients with cognitive problems, half of whom were given beepers that prompted "Time to take your medicine" twice a day. Those who were reminded took three times the number of pills as those who did not have the beeper, McArthur said. The study is being repeated using reminders via cell phones.

Examined at autopsy, HIV dementia's damage is to the basal ganglia, the same area affected in Parkinson's disease. Parkinson's destroys the cells; in AIDS dementia the problem is massive inflammation. Indeed, McArthur and colleagues have been testing the benefits of selegiline, a Parkinson's drug that blocks the inflammatory process. (Newsday (New York City), 10.15.02, Jamie Talan)

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This article was provided by Body Positive. It is a part of the publication Body Positive.